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| Dockets Entered
On March 6, 2007
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| Docket #
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| Title
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| 1985P-0067
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| ANDA SUITABILITY METHYLTESTOSTERONE 25MG
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| 1992P-0381
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| ANDA Suitability for Cytarabine Injection
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| 1992P-0500
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| ANDA suit for oral solution (syrup) dosage form trimethoprim
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| 1993P-0048
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| Cimetidine Effervescent tablets 200mg, 300mg, 400mg, & 800mg
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| 1993P-0314
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| Include Acetominophen and Codine Phosphate in 82N-0032
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| 1993P-0332
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| ANDA Suitability for Loperamide Hydrochloride 1 mg
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| 1993P-0333
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| ANDA Suitability for Prednisone Chewable Tablets, Oral
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| 1993P-0346
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| Butalbital, Acetaminophen, Caffeine and Hydrocodone
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| 1993P-0367
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| ANDA Suit for Terfenadine 60mg & Pseudoephedrine HCL 120mg
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| 1993P-0446
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| ANDA Morphine Sulfate controlled release capsules 15,60,mgs
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| 1993P-0459
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| ANDA Suit for Methyltestosterone 25 mg Tablets
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| 1994P-0182
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| ANDA Suit for 120 mg Acetaminophen & 12 mg Codeine Tablet
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| 1994P-0186
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| ANDA Suit for sulfamethoxadole-trimethoproim tablet
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| 1994P-0199
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| ANDA Suitability for Lorazepam Oral Solution
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| 1994P-0210
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| ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/60mg
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| 1994P-0211
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| ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/30mg
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| 1994P-0212
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| ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/15mg
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| 1994P-0263
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| ANDA Suitability for Fluorouracil Topical Gel 5% Strength
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| 1994P-0432
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| ANDA Suit - Immediate Release of Chewable Methyprednisolone
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| 1994P-0433
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| ANDA Suitability of Leucovorin Calcium Injection
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| 1995P-0008
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| ANDA Suitability for Captopril concentrated oral solution
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| 1995P-0100
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| ANDA suitability for carbidopa/levodopa powder
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| 1996P-0021
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| ANDA for a butalbital & Aspirin capsule (50 mg; 650mg).
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| 1996P-0054
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| ANDA for Potassium chloride Extended-release Microparticle s
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| 1996P-0079
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| ANDA for Pentoxifylline Extended-release Microparticle Pkts.
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| 1996P-0307
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| ANDA for Acyclovir Cream 5%
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| 1996P-0376
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| ANDA for Hydrocortisone Acetate 90mg Rectal Suppositories
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| 1996P-0510
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| ANDA for a Diltiazem Hydrochloride extended release tablet
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| 1997P-0155
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| ANDA for mefenamic acid tablets, 250mg.
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| 1997P-0192
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| ANDA suitability for a diltiazem hydrochloride extended rele
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| 1997P-0195
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| anda suitability for diltiazem hcl extended tablet, 120 180,
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| 1997P-0387
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| ANDA for sublingual tablet formulation of albuterol sulfate
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| 1997P-0404
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| ANDA Suitability for Famotidine 10mg Effervescent Tablets
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 1998P-0068
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| ANDA for topical emollient lotion clobetasol propionate
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| 1998P-0146
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| New dosage form of a certain anti-cancer drug product is sui
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| 1998P-0199
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| ANDA Suitability for Captopril oral solution
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| 1998P-0745
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| Econazole Nitrate Ointment
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| 2001D-0432
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| Evalution of the effects of Orally Inhaled and Intranasal
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| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| 2005N-0373
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| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
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| 2005N-0448
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| Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph
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| 2005P-0487
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| Require manufacturers to stop using xylene, toluene, and dibutyl phthalate in nail polish marketed for children under the age of 14.
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| 2006D-0336
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| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
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| 2006E-0024
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| Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569
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| 2006E-0516
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| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
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| 2006P-0210
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| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
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| 2007E-0010
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| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
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| 2007P-0079
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| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
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| 1985P-0067
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| ANDA SUITABILITY METHYLTESTOSTERONE 25MG
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| NWL 2
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| FDA
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| Vol #:
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| 1
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| 1990S-0308
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| Generic Drug Speeches & Policy and Procedure Guides
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| RPT 775
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| Statistical Report - Month of February 2007
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| Vol #:
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| 56
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| 1992P-0381
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| ANDA Suitability for Cytarabine Injection
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1992P-0500
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| ANDA suit for oral solution (syrup) dosage form trimethoprim
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0048
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| Cimetidine Effervescent tablets 200mg, 300mg, 400mg, & 800mg
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0314
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| Include Acetominophen and Codine Phosphate in 82N-0032
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0332
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| ANDA Suitability for Loperamide Hydrochloride 1 mg
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0333
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| ANDA Suitability for Prednisone Chewable Tablets, Oral
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0346
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| Butalbital, Acetaminophen, Caffeine and Hydrocodone
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0367
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| ANDA Suit for Terfenadine 60mg & Pseudoephedrine HCL 120mg
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0446
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| ANDA Morphine Sulfate controlled release capsules 15,60,mgs
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| |
|
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1993P-0459
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| ANDA Suit for Methyltestosterone 25 mg Tablets
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1994P-0182
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| ANDA Suit for 120 mg Acetaminophen & 12 mg Codeine Tablet
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| |
|
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1994P-0186
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| ANDA Suit for sulfamethoxadole-trimethoproim tablet
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| |
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| NWL 1
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| FDA
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| Vol #:
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| 1
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|
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| 1994P-0199
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| ANDA Suitability for Lorazepam Oral Solution
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| |
|
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| |
|
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| 1994P-0210
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| ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/60mg
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| |
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1994P-0211
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| ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/30mg
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| |
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1994P-0212
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| ANDA for Acet., Aspirin & Codeine Phosphate 150mg/180mg/15mg
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| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1994P-0263
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| ANDA Suitability for Fluorouracil Topical Gel 5% Strength
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| |
|
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| NWL 1
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| FDA
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| Vol #:
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| 1
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|
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| 1994P-0432
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| ANDA Suit - Immediate Release of Chewable Methyprednisolone
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| |
|
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| NWL 1
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| FDA
|
| Vol #:
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| 1
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| |
|
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| 1994P-0433
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| ANDA Suitability of Leucovorin Calcium Injection
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| |
|
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| NWL 1
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| FDA
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| Vol #:
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| 1
|
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|
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| 1995P-0008
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| ANDA Suitability for Captopril concentrated oral solution
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| |
|
|
| NWL 1
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| FDA
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| Vol #:
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| 1
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| 1995P-0100
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| ANDA suitability for carbidopa/levodopa powder
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| | | | | | | | |
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| |
|
| NWL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1996P-0021
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| ANDA for a butalbital & Aspirin capsule (50 mg; 650mg).
|
| |
|
|
| NWL 1
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| FDA
|
| Vol #:
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| 1
|
|
| |
|
| 1996P-0054
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| ANDA for Potassium chloride Extended-release Microparticle s
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| |
|
|
| NWL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1996P-0079
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| ANDA for Pentoxifylline Extended-release Microparticle Pkts.
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| |
|
|
| NWL 1
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| FDA
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| Vol #:
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| 1
|
| |
|
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| 1996P-0307
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| ANDA for Acyclovir Cream 5%
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| |
|
|
| NWL 1
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| FDA
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| Vol #:
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| 1
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| |
|
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| 1996P-0376
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| ANDA for Hydrocortisone Acetate 90mg Rectal Suppositories
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| |
|
|
| NWL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1996P-0510
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| ANDA for a Diltiazem Hydrochloride extended release tablet
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| |
|
|
| NWL 1
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| FDA
|
| Vol #:
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| 1
|
| |
|
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| 1997P-0155
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| ANDA for mefenamic acid tablets, 250mg.
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| |
|
|
| NWL 1
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| FDA
|
| Vol #:
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| 1
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| |
|
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| 1997P-0192
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| ANDA suitability for a diltiazem hydrochloride extended rele
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| |
|
|
| NWL 1
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| FDA
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| Vol #:
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| 1
|
|
| |
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| 1997P-0195
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| anda suitability for diltiazem hcl extended tablet, 120 180,
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| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1997P-0387
|
| ANDA for sublingual tablet formulation of albuterol sulfate
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| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1997P-0404
|
| ANDA Suitability for Famotidine 10mg Effervescent Tablets
|
| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
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| 1
|
| |
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
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| |
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|
| LET 19195
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19196
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| Enzymatic Therapy, Inc.
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| Vol #:
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| 172
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| LET 19197
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| LET 19198
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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| |
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| LET 19199
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| Enzymatic Therapy, Inc.
|
| Vol #:
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| 172
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|
| | | | | | | |
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| LET 19200
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19201
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19202
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19203
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19204
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19205
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19206
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
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|
| LET 19207
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19208
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19209
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
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| LET 19210
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
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| LET 19211
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
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| LET 19212
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19213
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
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| |
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| LET 19214
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| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19215
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19216
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19217
|
| NBTY Inc.
|
| Vol #:
|
| 172
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| |
|
|
| LET 19218
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19219
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19220
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19221
|
| Insight Pharmaceuticals, LLC
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19222
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19223
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19224
|
| NBTY Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19225
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19226
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19227
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19228
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19229
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19230
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19231
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19232
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19233
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19234
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19235
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19236
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
|
| | | | | | | | |
|
| |
|
| LET 19237
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19238
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19239
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19240
|
| Michael's Naturopathic Programs
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19241
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19242
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19243
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19244
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19245
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19246
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
| |
|
|
| LET 19247
|
| Perrigo Company of South Carolina
|
| Vol #:
|
| 172
|
|
| |
|
| 1998P-0068
|
| ANDA for topical emollient lotion clobetasol propionate
|
| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1998P-0146
|
| New dosage form of a certain anti-cancer drug product is sui
|
| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1998P-0199
|
| ANDA Suitability for Captopril oral solution
|
| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 1998P-0745
|
| Econazole Nitrate Ointment
|
| |
|
|
| NWL 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2001D-0432
|
| Evalution of the effects of Orally Inhaled and Intranasal
|
| |
|
|
| GDL 2
|
| Guidance
|
| Vol #:
|
| 1
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| |
|
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| NAD 2
|
| FDA
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| Vol #:
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| 1
|
|
| |
|
| 2003N-0573
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| Draft Animal Cloning Risk Assessment
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| |
|
|
| C 280
|
| Form Letter Count 9
|
| Vol #:
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| 27
|
| |
|
|
| C 281
|
| Form Letter Count 410
|
| Vol #:
|
| 28
|
| |
|
|
| C 282
|
| Form Letter Count 100
|
| Vol #:
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| 29
|
| |
|
|
| C 283
|
| C. Lane
|
| Vol #:
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| 23
|
| |
|
|
| C 284
|
| O. Mandrussow
|
| Vol #:
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| 23
|
| |
|
|
| C 285
|
| A. Troy
|
| Vol #:
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| 23
|
| |
|
|
| C 286
|
| D. White
|
| Vol #:
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| 23
|
| |
|
|
| C 287
|
| N. Vecchia
|
| Vol #:
|
| 23
|
| |
|
|
| C 288
|
| S. Lander
|
| Vol #:
|
| 23
|
| |
|
|
| C 289
|
| L. Staley
|
| Vol #:
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| 23
|
|
| | | | | | | | |
|
| |
|
| C 290
|
| G. Hillard
|
| Vol #:
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| 23
|
| |
|
|
| C 291
|
| K. Yoder
|
| Vol #:
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| 23
|
| |
|
|
| C 292
|
| D. Feil
|
| Vol #:
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| 23
|
| |
|
|
| C 293
|
| L. Smith
|
| Vol #:
|
| 23
|
| |
|
|
| C 294
|
| M. Geach
|
| Vol #:
|
| 23
|
| |
|
|
| C 295
|
| K. Mirise3
|
| Vol #:
|
| 23
|
| |
|
|
| C 296
|
| C. Thornton
|
| Vol #:
|
| 23
|
| |
|
|
| C 297
|
| C.White
|
| Vol #:
|
| 23
|
| |
|
|
| C 298
|
| C. Coker
|
| Vol #:
|
| 23
|
| |
|
|
| C 299
|
| K. Roark
|
| Vol #:
|
| 23
|
| |
|
|
| C 300
|
| S. Powers
|
| Vol #:
|
| 23
|
| |
|
|
| C 301
|
| B. Goode
|
| Vol #:
|
| 23
|
| |
|
|
| C 302
|
| E. Riddle
|
| Vol #:
|
| 23
|
| |
|
|
| C 303
|
| T. Wimbush
|
| Vol #:
|
| 23
|
| |
|
|
| C 304
|
| I. Carr
|
| Vol #:
|
| 23
|
| |
|
|
| C 305
|
| M. Murray
|
| Vol #:
|
| 23
|
| |
|
|
| C 306
|
| A. Montapert
|
| Vol #:
|
| 23
|
| |
|
|
| C 307
|
| D. Cox
|
| Vol #:
|
| 23
|
| |
|
|
| C 308
|
| R. Delapena
|
| Vol #:
|
| 23
|
| |
|
|
| C 309
|
| P. Wilder
|
| Vol #:
|
| 23
|
| |
|
|
| C 310
|
| B. Bonsigmore
|
| Vol #:
|
| 23
|
| |
|
|
| C 311
|
| C. Anderson
|
| Vol #:
|
| 23
|
| |
|
|
| C 312
|
| Form Letter Count 3
|
| Vol #:
|
| 30
|
| |
|
|
| 2005N-0373
|
| Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
|
| |
|
|
| C 4
|
| La Sierra University School of Business and Management
|
| Vol #:
|
| 2
|
| |
|
|
| EC 8
|
| Ms. Jennifer Pan
|
| Vol #:
|
| 2
|
| |
|
|
| 2005N-0448
|
| Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph
|
| |
|
|
| LET 1
|
| FDA to Colleague
|
| Vol #:
|
| 1
|
| |
|
|
| NFR 1
|
| FDA
|
| Vol #:
|
| 1
|
| |
|
|
| 2005P-0487
|
| Require manufacturers to stop using xylene, toluene, and dibutyl phthalate in nail polish marketed for children under the age of 14.
|
| |
|
|
| PDN 1
|
| FDA to U S Public Interest Research Group
|
| Vol #:
|
| 1
|
| |
|
|
| 2006D-0336
|
| Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
|
| |
|
|
| C 7
|
| Clinical Laboratory Management Association (CLMA)
|
| Vol #:
|
| 1
|
| |
|
|
| C 8
|
| Coalition for 21st Century Medicine
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| C 9
|
| Luminex Corporation
|
| Vol #:
|
| 1
|
| |
|
|
| C 10
|
| Nanogen Inc
|
| Vol #:
|
| 1
|
| |
|
|
| EC 15
|
| Association for Molecular Pathology
|
| Vol #:
|
| 1
|
| |
|
|
| EC 16
|
| Mayo Clinic Rochester
|
| Vol #:
|
| 1
|
| |
|
|
| EC 17
|
| Coalition for 21st Century Medicine
|
| Vol #:
|
| 1
|
| |
|
|
| EC 18
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 19
|
| Ventana Medical Systems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 20
|
| Claire Altman Heine Foundation, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 21
|
| KS
|
| Vol #:
|
| 1
|
| |
|
|
| EC 22
|
| Vision Biosystems
|
| Vol #:
|
| 1
|
| |
|
|
| EC 23
|
| Life Sciences Management Group, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 24
|
| Nanogen, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 25
|
| Nanogen, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 26
|
| Parent Project Muscular Dystrophy
|
| Vol #:
|
| 1
|
| |
|
|
| EC 27
|
| Incontinentia Pigmenti International Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 28
|
| Parent Project Muscular Dystrophy (PPMD)
|
| Vol #:
|
| 1
|
| |
|
|
| EC 29
|
| Trimethylaminuria Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 30
|
| Johnson
|
| Vol #:
|
| 1
|
| |
|
|
| EC 31
|
| Luminex Corp
|
| Vol #:
|
| 1
|
| |
|
|
| EC 32
|
| National Tay-Sachs
|
| Vol #:
|
| 1
|
| |
|
|
| EC 33
|
| National Tay-Sachs
|
| Vol #:
|
| 1
|
| |
|
|
| EC 34
|
| Washington Legal Foundation
|
| Vol #:
|
| 1
|
| |
|
|
| EC 35
|
| Genzyme Corp
|
| Vol #:
|
| 1
|
| |
|
|
| EC 36
|
| Advanced Medical Technology Association
|
| Vol #:
|
| 1
|
| |
|
|
| EC 37
|
| Genetic Alliance
|
| Vol #:
|
| 1
|
| |
|
|
| EC 38
|
| Ciphergen Biosystems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 39
|
| Ciphergen Biosystems, Inc.
|
| Vol #:
|
| 1
|
| |
|
|
| EC 40
|
| Celera
|
| Vol #:
|
| 1
|
| |
|
|
| EC 41
|
| Celera
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0024
|
| Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569
|
| |
|
|
| LET 5
|
| U.S. Patent and Tradmark Office to Weil, Gotshal & Manges LLP
|
| Vol #:
|
| 1
|
| |
|
|
| 2006E-0516
|
| Patent Extension Application for SPRYCEL (dasatinib), U.S. Patent No. 6,596,746
|
| |
|
|
| LET 4
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2006P-0210
|
| Amend regulations for products composed of engineered nanoparticles generally and sunscreen drug products composed of engineered nanoparticles specifically
|
| |
|
|
| LET 1
|
| FDA to International Center for Technology Assessment
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
| |
|
| 2007E-0010
|
| Patent Extension Application for Chantix (varenicline), U.S. Patent No. 6,410,550
|
| |
|
|
| LET 3
|
| U.S. Patent and Trademark Office to FDA/CDER (HFD-7)
|
| Vol #:
|
| 1
|
| |
|
|
| 2007P-0079
|
| To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
|
| |
|
|
| ACK 1
|
| FDA/DDM to David K. Richardson
|
| Vol #:
|
| 1
|
| |
|
|
| CP 1
|
| David K. Richardson
|
| Vol #:
|
| 1
|
|
|
